Re: Cholesterol Guidelines A Gift For Merck, Pfizer
From: GT (qwertn_at_so.no)
Date: 01/13/05
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Date: Thu, 13 Jan 2005 08:50:12 -0600
soon everyone can take a statin without a prescription!!!!!!
Selling Statins Over-the-Counter
FDA Weighs Whether to Let Patients Buy Cholesterol Drugs Without a
Prescription
By RON WINSLOW and ANNA WILDE MATHEWS
Should cholesterol-lowering statins, the biggest selling drugs in the
world, be available to consumers as easily as aspirin -- on drugstore
shelves without a prescription?
A joint venture between Merck & Co. and Johnson & Johnson is asking
for permission to sell a 20-milligram dose of Merck's Mevacor
over-the-counter, arguing that the step would extend the benefits of
the drugs to potentially millions of patients who currently aren't
taking them. Statins are a major weapon against heart attacks, strokes
and death from cardiovascular disease. A Food and Drug Administration
advisory panel will discuss the issue today, with its vote expected to
foreshadow the agency's ultimate decision.
The FDA, which is under scrutiny from Congress for its handling of
safety matters on painkillers and other drugs, so far is taking a
skeptical tone. An agency analysis sent to the panel concluded that
the joint venture's own study showed "the majority of consumers cannot
correctly self-select" to use Mevacor without assistance from a
health-care provider. Some of the study participants chose to take the
drug even though they didn't actually know their cholesterol levels.
The outcome will be important in a far larger debate that has grown as
Internet-educated consumers seek to take more control of their
health-care choices. The key question is which decisions patients can
make on their own -- and which should be left to a doctor. Whatever
happens with Mevacor, the issue will come up again: Bristol-Myers
Squibb Co. has said it plans a new attempt to switch its own statin,
Pravachol, to over-the-counter.
The statins are a landmark test of the FDA's thinking on
over-the-counter medicines. Traditionally, drugstores carry remedies
for short-term problems, such as headaches. But statins have to be
taken for a long period of time to tame chronically high cholesterol,
which doesn't have symptoms. Patients would have to decide for
themselves whether they need the drug, and monitor their own progress.
In the United Kingdom, regulators allow consumers to buy a different
statin, Zocor, over-the-counter. But that program included a big role
for pharmacists in advising patients, a structure that may not be easy
to duplicate in the U.S., where consumers are used to grabbing their
medicines off the shelf.
In the U.S., where an FDA advisory panel in 2000 turned down
over-the-counter requests for Mevacor and Pravachol, many doctors
remain skeptical that consumers can manage their own risks for
something as serious as heart disease. "Statins are strong medicines
for a condition that is potentially life-threatening," says Steven
Nissen, a cardiologist at the Cleveland Clinic. They "should be
prescribed by physicians with the training and experience...to choose
the right thing for the right patient at the right time."
People who have suffered a heart attack or are otherwise at high risk
of cardiovascular disease are candidates for aggressive treatment with
high-dose statins. The goal is to get their LDL, or "bad," cholesterol
to as low as below 70. The aim with a less-potent over-the-counter
statin would be to avoid a first heart attack or stroke in patients at
intermediate risk. The joint venture, Johnson & Johnson/Merck, says
that amounts to 15 million to 20 million Americans, whose LDL is
moderately elevated -- between 130 and 170. National guidelines advise
them to get LDL below 130. Yet only three million to five million of
them are getting treatment because, among other reasons, they aren't
seeing a doctor regularly, they lack insurance or their doctors aren't
effectively monitoring their risks.
Switching to over-the-counter would ease access and potentially reduce
costs, the drug makers say. And at 20 milligrams, the companies say
the Mevacor dosage would be effective enough to reduce LDL in this
moderate-risk population while still having a low risk of side
effects.
Merck and Johnson & Johnson say their program can ensure that the
right patients take Mevacor. The plan entails a "self management
system" that includes, among other things, detailed criteria noted in
the packaging to help consumers decide whether their LDL cholesterol,
age and other risk factors make them candidates for Mevacor. The
packaging also directs consumers to a Web site and a toll-free call
center for information and a cholesterol-testing referral service.
Consumers are encouraged to contact their doctors.
As a test of how well consumers can choose, the companies mounted an
unusual study intended to mimic real-world practice. They set up 14
mock storefront drugstores in seven regions of the U.S., with products
lined up on shelves and a nurse to represent a pharmacist. They
recruited customers to come in and consider Mevacor as an
over-the-counter drug. All told, 3,316 people showed up, of whom 1,061
decided to purchase the medicine. These people then were tracked for
six months.
The companies' researchers concluded that 84% of the participants made
an "appropriate" initial decision on whether to purchase the drug,
based on whether they met criteria listed in the product label. But
that number included everyone who decided against making a purchase:
The companies viewed those consumers as having made a correct
decision, though there was no follow-up.
Of the consumers who did choose to take the drug, 66% met or came
close to meeting the criteria, according to the analysis. During the
study, 23 participants, or 2%, either took Mevacor with drugs that
could cause adverse reactions or otherwise used the medicine in a
fashion that raised risks, though no serious consequences resulted.
The study, which was published in November in the American Journal of
Cardiology, found that of 878 participants who had their cholesterol
measured after six months, 548, or 62%, got their LDL to a target
below 130. And the study prompted many participants to contact their
doctors -- a result company officials regard as an indication the
program works.
But the FDA said the study didn't reflect real-world conditions.
According to the FDA's own analysis, just 55% of participants made the
right decision about whether to take Mevacor, and only 41% correctly
continued to use the drug by the sixth week. The biggest problem was
that consumers didn't know their total cholesterol profile. Among
people who said they did know, only half accurately identified their
LDL.
The FDA also raised questions about whether consumers would use a
statin safely without oversight from a doctor. The FDA reviewer
cautioned that because the study limited the amount of Mevacor
consumers could buy, it didn't truly reflect the risk of overdosing.
The agency also questioned whether consumers should take the drug
without a requirement for a doctor to test periodically for liver
problems, a possible side effect of statins, and whether patients
would be cautious enough about interactions with other drugs and
substances.
Statins have built up an impressive record on both safety and
effectiveness during more than 15 years on the market. But the class
has blemishes too: Bayer AG pulled its statin Baycol from the market
in 2001 because of a heightened risk of a very rare but potentially
lethal muscle-wasting side effect called rhabdomyolysis, and
AstraZeneca PLC's Crestor has been hobbled by worries about similar
side effects, especially at high doses.
Another concern is that patients at high risk of heart attack or
stroke might not get all the treatment they need. "We would not want
people who had heart disease that required very aggressive treatment
to think that all they need to do is take a low-dose statin," says
Sidney Smith, a cardiologist at the University of North Carolina at
Chapel Hill.
STATIN TARGETS
A proposed over-the-counter 20 milligram dose of Mevacor would be
aimed at:
• Men 45 and older and women 55 and older
• With LDL between 130 and 170
• And at least one of these heart-disease risks: a smoker; HDL (good
cholesterol) of 39 or under; high blood pressure; heart disease in a
father or brother before age 55 or in a mother or sister before 65
Source: Merck & Co.
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